The following data is part of a premarket notification filed by Medacta Inernational Sa with the FDA for Mectalif Transforaminal Tipeek.
| Device ID | K200551 |
| 510k Number | K200551 |
| Device Name: | MectaLIF Transforaminal TiPEEK |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Medacta Inernational SA Strada Regina Castel San Pietro, CH Ch-6874 |
| Contact | Stefano Baj |
| Correspondent | Chris Lussier Medacta USA 3973 Delp Street Memphis, TN 38118 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-03 |
| Decision Date | 2021-02-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030829598 | K200551 | 000 |
| 07630030829420 | K200551 | 000 |
| 07630030829413 | K200551 | 000 |
| 07630030829406 | K200551 | 000 |
| 07630030829390 | K200551 | 000 |
| 07630030829383 | K200551 | 000 |
| 07630030829376 | K200551 | 000 |
| 07630030829369 | K200551 | 000 |
| 07630030829352 | K200551 | 000 |
| 07630030829345 | K200551 | 000 |
| 07630030829338 | K200551 | 000 |
| 07630030829321 | K200551 | 000 |
| 07630030829314 | K200551 | 000 |
| 07630030829307 | K200551 | 000 |
| 07630030829291 | K200551 | 000 |
| 07630030829437 | K200551 | 000 |
| 07630030829444 | K200551 | 000 |
| 07630030829581 | K200551 | 000 |
| 07630030829574 | K200551 | 000 |
| 07630030829567 | K200551 | 000 |
| 07630030829550 | K200551 | 000 |
| 07630030829543 | K200551 | 000 |
| 07630030829536 | K200551 | 000 |
| 07630030829529 | K200551 | 000 |
| 07630030829512 | K200551 | 000 |
| 07630030829505 | K200551 | 000 |
| 07630030829499 | K200551 | 000 |
| 07630030829482 | K200551 | 000 |
| 07630030829475 | K200551 | 000 |
| 07630030829468 | K200551 | 000 |
| 07630030829451 | K200551 | 000 |
| 07630030829284 | K200551 | 000 |